The purpose of this study is to determine if there is a difference in opioid requirements at 0-48 hours after scheduled cesarean delivery in patients receiving 150 mcg intrathecal morphine compared to 0.2 mg/kg (maximum 20 mg) intravenous methadone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Subjects will receive standardized spinal anesthesia without intrathecal morphine (intrathecal 1.6-2 mL 0.75% bupivacaine + dextrose, 15 mcg fentanyl) and intravenous methadone (0.2mg/kg total body weight up to max dose of 20 mg, with saline added to make total volume 2 mL) The Intravenous line (IV) methadone will be administered after cord clamping and administration of uterotonics with the dose of medication divided into 4 equal aliquots each administered 5 minutes apart.
Subjects will receive standardized spinal anesthesia with intrathecal morphine 150 micrograms and no methadone (2cc dose of IV normal saline) The Intravenous line (IV) saline will be administered after cord clamping and administration of uterotonics with the dose of medication divided into 4 equal aliquots each administered 5 minutes apart.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Total opioid consumption
Total opioid consumption of either intrathecal opiate or intravenous methadone at 24-48 hours after delivery.
Time frame: 24 hours post-delivery, 48 hours post-delivery
Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool
The Obstetric Quality of Recovery-10 (ObsQoR-10), is a patient-reported 10-item questionnaire used to assess quality of recovery following spinal administration of pain medication. Patients rate each recovery item on a scale of 0 to 10, with 0 = worst possible recovery and 10 = best possible recovery. Total score ranges from 0-100 with higher scores indicating a better recovery after childbirth.
Time frame: 24 hours, 48 hours, 7 days
Numeric Rating Scale (NRS) pain score at rest
A Numeric Rating Scale (NRS) for pain is a patient-reported item regarding the level of pain experienced at rest and is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable".
Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days
Numeric Rating Scale (NRS) for movement-evoked pain
A Numeric Rating Scale (NRS) score for movement-evoked pain is a patient-reported item regarding the level of pain experienced with provoking maneuvers such as cough, inspiration/expiration, sitting up, knee flexion, hip flexion, rolling over in bed, and walking. The NRS is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable".
Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days
Numeric Rating Scale (NRS) for pain in previous 24 hours
A Numeric Rating Scale (NRS) score for highest level of pain is a patient-reported item regarding the level of pain experienced in the last 24 hours. The NRS is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable".
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days
Pruritus
The severity of pruritus post spinal administration will be patient-reported on a 4-point Likert scale where 0 = none and 3 = severe.
Time frame: 12 hours, 24 hours, 36 hours, 48 hours
Richmond Agitation Sedation Scale (RASS)
The Richmond Agitation Sedation Scale (RASS) will be used to assess the level of alertness and agitated behavior in patients. The patient's level of consciousness and sedation are rated by care provider, ranging from a combative state (+4) to an unarousable state (-5), with a "calm and alert" score at 0.
Time frame: 12 hours, 24 hours, 36 hours, 48 hours